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Sun Pharma’s travails with US regulator may drag on

Mumbai, March 08, 2018: Sun Pharmaceutical’s troubles with the US drug regulator will continue, as details of the recent observations revealed that the resolution of issues at its Halol manufacturing plant might take longer than expected.

Shares of Sun Pharma BSE -1.85 % fell by 3 per cent on Tuesday’s trading session as analysts raised doubts about the plant getting clearance in FY19.

The company received the Form 483 warning letter from the US Food and Drug Administration after it came for reinspection in February this year according to economictimes.indiatimes.com.

The USFDA noted that Sun Pharma was “deficient regarding operations related to aseptic processing of drugs, its procedures for cleaning and maintenance failed to include sufficient detail of the methods of disassembling and reassembling equipment and there are lack of procedures to describe sampling, testing and approval and rejection of drug product containers”.

Although the USFDA did not find any data integrity violations, analysts said that one of the observations will require the company to redesign civil work inside the plant.

“We believe the observation will require minimum 3-6 months to redesign the filing lines (approved by FDA) followed by civil works, which could facilitate efficient aseptic practices including process of cleaning vials and lack of possibility for air-flow contamination,” said Surjit Pal, analyst with Prabhudas Lilladher. He added that the whole process may lead to shut down (at least partially) of filing lines of the current production of injectable and impact revenues of US exports of injectable products.

The Pharma Times News Bureau